Federal officials have cleared the Johnson & Johnson covid-19 vaccine for use in the United States once again, albeit with an updated label to warn of blood clot risks.
The U.S. Food and Drug Administration and the Centres for Disease Control and Prevention called for a pause on the vaccine’s use on April 13 in response to a small number of reports potentially linking the one-dose vaccine to severe blood clotting. Of the nearly 8 million Americans who have received the vaccine so far, the agencies said they’ve confirmed 15 cases of people developing thrombosis-thrombocytopenia syndrome (TTS), characterised by falling blood platelet levels and a rare and severe type of blood clot that forms in the brain. All of these cases involved women between the ages of 18 and 59. Symptoms began to develop within six to 15 days after receiving the shot.
The FDA and CDC lifted their recommended pause on Friday following an extensive investigation, consultations with providers and clinicians, and a positive recommendation from the CDC’s Advisory Committee for Immunization Practices. In a joint statement, acting FDA commissioner Janet Woodcock said health regulators had concluded the J&J vaccine’s benefits “outweigh its known and potential risks.”
“We are confident that this vaccine continues to meet our standards for safety, effectiveness and quality,” she said. “We recommend people with questions about which vaccine is right for them have those discussions with their health care provider.”
Available data suggests that the chance of vaccine recipients developing TTS is very low, according to the agencies’ findings. Nonetheless, they will continue to investigate the risk and monitor cases as the J&J vaccine begins rolling out once more. Federal guidance about the vaccine for health care providers, recipients, and caregivers has also been updated to include information about the risk of blood clotting.
“Above all else, health and safety are at the forefront of our decisions,” CDC director Rochelle Walensky said in Friday’s statement. “Our vaccine safety systems are working. We identified exceptionally rare events – out of millions of doses of the [J&J vaccine] administered – and we paused to examine them more carefully. As we always do, we will continue to watch all signals closely as more Americans are vaccinated.”